PK Study of Dapagliflozin in Pediatric Subjects With T2DM

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Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).

Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin [ Time Frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose ]

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).

Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)

Time of maximum observed plasma concentration (Tmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ]

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ]

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ]

Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).

Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose ]

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).

Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours.

Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting [ Time Frame: Day 1 (Pre-dose) to Day 2 ]

Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL).

Mean Change in Fasting Plasma Glucose From Baseline Until Day 2 [ Time Frame: Day 1 (Pre-dose) to Day 2 ]

Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL).

Mean Total Amount of Glucose Excreted in Urine Over 24 Hours [ Time Frame: Time of dose to 24 hours post-dose, Day 1 to Day 2 ]

The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams.

Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration. [ Time Frame: Day 1 to Day 3 ]

Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported.

Number of Participants With Marked Hematology Laboratory Abnormalities [ Time Frame: Day 1 (Pre-dose) to Day 3 ]